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Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00004246
First received: January 28, 2000
Last updated: July 27, 2012
Last verified: July 2012

January 28, 2000
July 27, 2012
May 2000
February 2001   (final data collection date for primary outcome measure)
Maximum Tolerated Dose (MTD) of Fludarabine During Sixth & Seventh Weeks of Radiotherapy [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
MTD based on systemic toxicity of drug and acute mucosal reactions in the irradiated fields.
Not Provided
Complete list of historical versions of study NCT00004246 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx
A Phase I Study of Fludarabine With Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus fludarabine in treating patients who have locally advanced cancer of the mouth, pharynx, or larynx.

OBJECTIVES: I. Determine the maximum tolerated dose of fludarabine that can be given during the sixth and seventh weeks of radiotherapy in patients with locally advanced squamous cell carcinoma of the oral cavity, pharynx, or larynx, based on the systemic toxicity of the drug and the acute mucosal reactions in the irradiated fields. II. Document the qualitative and quantitative toxicity of this combination therapy in this patient population.

OUTLINE: This is a dose escalation study of fludarabine. Patients receive radiotherapy on days 1-5 for 7 weeks. Patients receive fludarabine IV on days 1-5 of weeks 6 and 7 of radiotherapy. Fludarabine is administered 3-4 hours prior to daily radiotherapy. Cohorts of 3 patients receive escalating doses of fludarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose that produces a severe toxicity rate nearest to 20%. Patients are followed every 4 weeks after the completion of treatment until acute reactions have resolved, then every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for this study within 1.5 years.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: Fludarabine Phosphate
    IV on days 1-5 of weeks 6 and 7 of radiotherapy, administered 3-4 hours prior to daily radiotherapy.
    Other Names:
    • Fludara
    • Fludarabine
  • Radiation: Radiation Therapy (RT)
    Days 1-5 for 7 weeks
    Other Name: radiotherapy
Experimental: RT + Fludarabine
Radiotherapy (RT) on Days 1-5 for 7 weeks + Fludarabine IV, 3-4 hours prior to daily RT, Days 1-5 of weeks 6 and 7 of RT
Interventions:
  • Drug: Fludarabine Phosphate
  • Radiation: Radiation Therapy (RT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2002
February 2001   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the oral cavity, pharynx, or larynx for which surgery would result in significant functional impairment Stage III or IV (T3-4 or N2-3) No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 6 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT less than 4 times upper limit of normal PT/PTT normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No other concurrent acute illness or infection

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004246
ID95-038, P30CA016672, P01CA006294, MDA-ID-95038, NCI-H99-0046, CDR0000067492
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: K. Kian Ang, MD, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP